December 8, 2010

FDA Advisory Panel Approves New Obesity Drug

by ssavage

A Food and Drug Administration (FDA) advisory panel has given their blessing to a new anti-obesity drug, which is now one step closer to becoming the first new weight-loss medication to receive federal approval in over a decade.

The drug in question, Contrave, was developed by La Jolla, California-based Orexigen Therapies. It is the third weight-loss medicine to be reviewed by an FDA advisory panel this year, but unlike the two before it (Qnexa and Loracserin), Contrave was approved by a 13-7 vote.

According to AFP reports, "The panel said the drug was only modestly effective and was found to cause slight boosts in blood pressure and pulse. It also urged a wider trial to assess potential heart attack risks."

The denial of Qnexa and Loracserin came in part due to heart-related concerns, and the agency asked Abbott Laboratories to pull their anti-obesity drug Meridia from store shelves two months ago due to the discovery of increased heart problems during European tests, the French news agency said.

The Associated Press (AP) said that Contrave, which is a blend of an antidepressant and an anti-addiction medication, had been linked to side effects such as high blood pressure, dizziness, and insomnia.

The AP also reported that Orexigen "didn't quite meet all the criteria the agency had set for obesity drugs," showing only a 4.2 percent increase in weight loss versus placebo while FDA guidelines mandate a minimum 5 percent difference between the two.

In an interview with the AP, Orexigen President and CEO Michael A. Narachi said that the meeting with the FDA panel "was incredibly valuable across the board on the input"¦ We look forward to incorporating the input we got today to move the program forward."

According to Susan Heavey of Reuters, panel chairman Abraham Thomas, the head of endocrinology at Henry Ford Hospital in Detroit, said that one of the main reasons he voted to approve Contrave was "concern" that rejecting medications that help combat obesity "will potentially kill development of these medications, and it is the most serious disease that the United States is facing."